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RED HOT Contributors


STAT Plus: ‘Unacceptable secrecy’ surrounds safety warnings by pharma and regulators in Australia


When a new safety issue arises with a medicine, regulators typically publicize advisories so that not just physicians, but also the public is made aware. At least, this is what happens in the U.S. and most European countries — but not in Australia, where researchers found that “unacceptable secrecy” surrounds such warnings and may jeopardize public health.

Unlike regulators elsewhere, the Therapeutics Goods Administration in Australia does not post on its website letters sent to doctors about new drug risks. So the researchers identified 207 drugs from 39 companies for which public warnings about heart failure, seizures, or death were issued in the U.S., the U.K., and Canada between 2007 and 2016, but not in Australia.

Continue to STAT Plus to read the full story…


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